Lung Cancer Clinical Trial
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
Summary
The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).
Full Description
Lung cancer is one of the most frequently diagnosed cancers and the leading cause of cancer related deaths worldwide. It is a heterogenous disease and is broadly classified as non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study will combine the 2 mesenchymal-epithelial transition (MET) inhibitors, amivantamab and capmatinib, which have different mechanisms of MET inhibition and, as monotherapies, have demonstrated clinical activity in MET driven NSCLC. Amivantamab is a bispecific antibody that targets both the epidermal growth factor receptor (EGFR) and MET extracellular ligand binding domains and inhibits ligand driven signaling. Capmatinib is a selective, oral MET tyrosine kinase inhibitor (TKI) that inhibits the MET downstream signaling pathway and thereby inhibits tumor growth and progression. The primary hypothesis of the study is that amivantamab and capmatinib can be safely administered as a combination therapy, with a tolerable safety profile (Phase 1), and the combination of amivantamab and capmatinib will demonstrate clinically significant anti-tumor activity for participants with NSCLC harboring MET exon 14 skipping mutations or MET amplification (Phase 2). The study will include a screening period, a treatment period , and a post-treatment follow-up period. The overall duration of the study will be up to 2 years 1 month.
Eligibility Criteria
Inclusion Criteria:
Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion Criteria:
Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids >10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 87 Locations for this study
Orange California, 92868, United States
Whittier California, 90603, United States
Chicago Illinois, 60637, United States
Bronx New York, 10467, United States
Chapel Hill North Carolina, 27599, United States
Fairfax Virginia, 22031, United States
Milwaukee Wisconsin, 53226, United States
Belo Horizonte , 30130, Brazil
Curitiba , 80810, Brazil
Pelotas , 96020, Brazil
Porto Alegre , 90610, Brazil
Rio de Janeiro , 22250, Brazil
Rio de Janeiro , 22281, Brazil
Salvador , 40170, Brazil
Sao Paulo , 01509, Brazil
São Paulo , 01308, Brazil
Ottawa Ontario, K1Y 4, Canada
Toronto Ontario, M5G 1, Canada
Beijing , 10014, China
Chengdu , 61004, China
Chengdu , 61004, China
Chongqing , 40003, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Harbin , 15008, China
Huizhou , 51600, China
Shanghai , 20003, China
Shanghai , 20043, China
Shenyang , 11005, China
Xi'An , 71006, China
Yantai , 26400, China
Zhengzhou , 45000, China
Lille , 59000, France
Lyon Cedex 8 , 69008, France
Marseille , 13005, France
PARIS Cedex 5 , 75248, France
Saint-Herblain Cedex , 44805, France
Strasbourg cedex , 67091, France
Berlin , 12203, Germany
Berlin , 14165, Germany
Chemnitz , 09116, Germany
Dresden , 01307, Germany
Essen , 45147, Germany
Koeln , 50937, Germany
Muenster , 48149, Germany
München , 81925, Germany
Milano , 20133, Italy
Milano , 20162, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Ravenna , 48121, Italy
Rome , 00128, Italy
Nagoya-shi , 460-0, Japan
Sunto-gun , 411-8, Japan
Tokyo , 135-8, Japan
Cheongju-si , 28644, Korea, Republic of
Goyang-Si , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seongnam , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Gdansk , 80-21, Poland
Lublin , 20-60, Poland
Warszawa , 02-78, Poland
A Coruña , 15006, Spain
Alicante , 03010, Spain
Barcelona , 08003, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Ankara , 06520, Turkey
Ankara , 06560, Turkey
Ankara , 06590, Turkey
Ankara , 06680, Turkey
Istanbul , 34098, Turkey
Istanbul , 34722, Turkey
London , NW1 2, United Kingdom
London , W2 1N, United Kingdom
Newcastle , NE7 7, United Kingdom
Sutton , SM2 5, United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.